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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 31, 2018 FBO #6033
DOCUMENT

J -- 36C258189435 Radiopharmaceutical Yttrium-90 resin microspheres - Attachment

Notice Date

5/29/2018
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;NCO22-Gilbert Network Contracting;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

36C25818Q9435
 

Response Due

5/31/2018
 

Archive Date

7/30/2018
 

Point of Contact

Abdalia "Dale" Smith
 

Small Business Set-Aside

N/A
 

Description

This is NOT a solicitation announcement. This sources sought notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). The purpose of this sources sought is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325412 - Pharmaceutical Preparation Manufacturing (size standard of 1250 Employees). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office Gilbert, is seeking sources that can provide Radiopharmaceutical Yttrium-90 resin microspheres for the Southern Arizona VA Healthcare System located at 3601 South 6th Avenue, Tucson, Arizona 85723. The facility s Radionuclide Use Permit is #02-06186-01. The period of performance will be as follows: Base Year: 1 July 2018 30 June 2019 Option Year 1: 1 July 2019 30 June 2020 Option Year 2: 1 July 2020 31 June 2021 Option Year 3: 1 July 2021 31 June 2022 Option Year 4: 1 July 2022 31 June 2023 The delivery location is Southern Arizona VA Health Care System, Building 38 Nuclear Medicine Hot Lab, Tucson, AZ 85723. Statement of Work Contractor shall provide Yttrium-90 resin microspheres for the Southern Arizona VA Health Care System, Tucson, AZ. Services shall be provided directly to the Nuclear Medicine Hot Lab. Services shall be for the support of VA beneficiaries. The Government shall ensure all routine orders for Yttrium-90 resin microsphere doses will be placed by the VAMC to the Contractor a minimum of three business days prior to treatment and before the clinic close of business via phone or internet. The order will include specified activities of doses and calibration times. Specific Tasks The Contractor shall provide any training or education, required to meet commercial standards related to use of the radiopharmaceutical (Yttrium-90) to qualified Nuclear Medicine staff, Interventional Radiology staff, and the Radiation Safety Officer at SAVAHCS. The Contractor shall provide any documentation required to meet commercial standards related to use of the radiopharmaceutical (Yttrium-90) resin microspheres. The Contractor shall obtain, maintain, and provide evidence at the request of the Government, U.S. Food & Drug Administration (FDA) approval of the Yttrium-90 resin microspheres. PACKAGING AND MARKING The contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations. Items must be properly packaged to prevent damage during shipping, handling, and storage. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State). Holidays Normal business hours are 8 a.m. to 4:30 p.m., Monday through Friday excluding the following federal holidays: New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas, and any other day specifically declared by the President of the United States to be a national holiday. Ordering The Contractor shall provide personnel for orders for Yttrium-90 resin microspheres to be placed during standard hours of care Monday through Friday from 0800 (8:00 AM AZT) until 1630 hours (4:30 PM AZT), not including Federal holidays. Upon the order being placed, the Contractor is to send confirmation to the ordering VAMC official via email. The Contractor shall receive orders for Yttrium-90 resin microspheres from the Nuclear Medicine section of SAVAHCS Radiology Service. The Contractor shall ensure the Nuclear Medicine staff name and contact information that placed the order is included. The Contractor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose per specific requirements provided by the Nuclear Medicine section based on Nuclear Regulatory Commission guidelines outlined in 10 CFR Part 35 Medical Uses of Byproduct Material. The Contractor shall notify VAMC Nuclear Medicine section immediately should the inability arise to provide Radiopharmaceutical (Yttrium-90) doses by the required date and time. Delivery Requirements: The Contractor shall deliver ordered Radiopharmaceutical doses to: Department of Veterans Affairs Southern Arizona VA Healthcare System Building 38 Nuclear Medicine, Hot Lab Tucson, Arizona 85723 The Contractor shall ensure all orders are to be delivered by 0730 (AZT) on the day specified or prior to the day specified to ensure proper inventory and receipt of the shipment is done by qualified personnel. The Contractor shall provide a daily packing slip accompanying all Radiopharmaceutical shipments to the Nuclear Medicine section for all orders placed. The Contractor shall ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist. The Contractor shall provide courier service that is in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of all Yttrium-90 resin microspheres. All couriers shall be licensed and shall submit all required paperwork in order to be granted access to VAMC. SCHEDULE ITEM# ITEM NAME ESTIMATED QTY 0001 SIR-Spheres Microspheres 6 The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested, and are capable of providing the sought-out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc. (2) Is your company considered small under the NAICS code identified under this source sought announcement? (3) Are you the manufacturer or distributor of the items being referenced above? What is the manufacturing country of origin of these items? (4) If you re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have a Federal Supply Schedule (FSS) contract with General Services Administration (GSA) or the National Acquisition Center (NAC) or are you a contract holder with NASA SEWP (National Aeronautics and Space Administration / Solutions for Enterprise-Wide Procurement) or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please submit your capabilities in regards to the salient characteristics being provided for planning purposes. *** Submissions addressing Section (8) should show clear, compelling and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to abdalia.smith@va.gov. Telephone responses will not be accepted. Responses must be received no later than Thursday, May 31, 2018 at 4 PM PST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/36C25818Q9435/listing.html)
 

Document(s)

Attachment
 

File Name: 36C25818Q9435 36C25818Q9435.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4340849&FileName=36C25818Q9435-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4340849&FileName=36C25818Q9435-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04936487-W 20180531/180529230821-16cc05aa9ad6a9c2cc413256d7554a7d (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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